The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without the device to analyze, the reported positioning failure (straighten ¿ unable) was due to the cable break.The cause of the reported cable break could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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This is filed to report a cable break and inability to straighten the device.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr).During preparation of the steerable guide catheter (sgc), the +/- knob was turned 3/4 of a turn in the minus direction and then the cable snapped.Applying "-" knob then no longer functioned and could be rotated freely in that direction, but the "+" knob still functioned.A replacement sgc was used to complete the procedure.There was no patient involved with the issue and no clinically significant delay.No additional information was provided.
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